ID

20888

Descrição

Comparison of Monodose and Multidose Presentations of GSK Biologicals' Hepatitis B Vaccine in Terms of Immune Response; ODM derived from: https://clinicaltrials.gov/show/NCT00197158

Link

https://clinicaltrials.gov/show/NCT00197158

Palavras-chave

Versões (1)
  1. 25/03/2017 25/03/2017 -
Transferido a

25 de março de 2017

DOI

Para um pedido faça login.

Licença

Creative Commons BY-NC 3.0
Comentários do modelo :

Aqui pode comentar o modelo. Pode comentá-lo especificamente através dos balões de texto nos grupos de itens e itens.

Voltar para os comentários do modelo
Comentários do grupo de itens para :

Comentários do item para :

Para descarregar formulários, precisa de ter uma sessão iniciada. Por favor faça login ou registe-se gratuitamente.

Eligibility Hepatitis B NCT00197158

Inglês

Eligibility Hepatitis B NCT00197158

1 Formulários  
Inclusion Criteria
Descrição

Inclusion Criteria

Alias
UMLS CUI
C1512693
a male or female >= 18 years of age
Descrição

Age

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0001779
written informed consent obtained from the subject.
Descrição

Informed Consent

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0021430
free of obvious health problems as established by medical history and clinical examination before entering into the study.
Descrição

Health Problem Free of | Medical History | examination; clinical

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0018684
UMLS CUI [1,2]
C0033213
UMLS CUI [1,3]
C0332296
UMLS CUI [2]
C0262926
UMLS CUI [3]
C1456356
if the subject is female, she must be of non-childbearing potential, i.e. either surgically sterilized or one year post-menopausal; or, if of childbearing potential, she must be abstinent or have used adequate contraceptive precautions for 30 days prior to vaccination, have a negative pregnancy test and must agree to continue such precautions for two months after completion of the vaccination series.
Descrição

Gender Childbearing Potential Absent | Female Sterilization | Postmenopausal state | Childbearing Potential Sexual Abstinence | Childbearing Potential Contraceptive methods | Childbearing Potential Pregnancy test negative | Vaccination

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0079399
UMLS CUI [1,2]
C3831118
UMLS CUI [1,3]
C0332197
UMLS CUI [2]
C0015787
UMLS CUI [3]
C0232970
UMLS CUI [4,1]
C3831118
UMLS CUI [4,2]
C0036899
UMLS CUI [5,1]
C3831118
UMLS CUI [5,2]
C0700589
UMLS CUI [6,1]
C3831118
UMLS CUI [6,2]
C0427780
UMLS CUI [7]
C0042196
Exclusion Criteria
Descrição

Exclusion Criteria

Alias
UMLS CUI
C0680251
use of any investigational or non-registered drug or vaccine other than the study vaccine during the study period.
Descrição

Investigational New Drugs | Drugs, Non-Prescription | Vaccine OTC - Over The Counter | Vaccine Clinical Trial

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0013230
UMLS CUI [2]
C0013231
UMLS CUI [3,1]
C0042210
UMLS CUI [3,2]
C2709201
UMLS CUI [4,1]
C0042210
UMLS CUI [4,2]
C0008976
chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within six months prior to the first vaccine dose. (for corticosteroids, this will mean prednisone, or equivalent, greater than or equal to 0.5 mg/kg/day. inhaled and topical steroids are allowed.)
Descrição

Immunosuppressive Agents chronic | Biological Response Modifiers chronic | Adrenal Cortex Hormones | Prednisone U/day | Prednisone equivalent U/day | inhaled steroids | topical steroids

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0021081
UMLS CUI [1,2]
C0205191
UMLS CUI [2,1]
C0005525
UMLS CUI [2,2]
C0205191
UMLS CUI [3]
C0001617
UMLS CUI [4,1]
C0032952
UMLS CUI [4,2]
C0456683
UMLS CUI [5,1]
C0032952
UMLS CUI [5,2]
C3242703
UMLS CUI [5,3]
C0456683
UMLS CUI [6]
C2065041
UMLS CUI [7]
C2064827
planned administration/ administration of a vaccine not foreseen by the study protocol within 30 days of the first dose of vaccine.
Descrição

Vaccine | Vaccine Planned

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0042210
UMLS CUI [2,1]
C0042210
UMLS CUI [2,2]
C1301732
previous vaccination against hepatitis b
Descrição

Hepatitis B vaccination

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0474232
history of hepatitis b infection
Descrição

Hepatitis B

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0019163
known exposure to hepatitis b within the previous 6 weeks
Descrição

Hepatitis B Exposure to

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0019163
UMLS CUI [1,2]
C0332157
any confirmed or suspected immunosuppressive or immunodeficient condition, including human immunodeficiency virus (hiv) infection.
Descrição

Immunosuppression | Immunologic Deficiency | Immunosuppression Suspected | Immunologic Deficiency Suspected | HIV Infections

Tipo de dados

boolean

Alias
UMLS CUI [1]
C4048329
UMLS CUI [2]
C0021051
UMLS CUI [3,1]
C4048329
UMLS CUI [3,2]
C0750491
UMLS CUI [4,1]
C0021051
UMLS CUI [4,2]
C0750491
UMLS CUI [5]
C0019693
a family history of congenital or hereditary immunodeficiency.
Descrição

Immunodeficiency congenital Family history | Immunologic Deficiency Hereditary Family history

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0853602
UMLS CUI [1,2]
C0241889
UMLS CUI [2,1]
C0021051
UMLS CUI [2,2]
C0439660
UMLS CUI [2,3]
C0241889
history of allergic disease or reactions likely to be exacerbated by any component of the vaccine(s).
Descrição

Hypersensitivity Exacerbated Caused by Vaccine Component | Allergic Reaction Exacerbated Caused by Vaccine Component

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C1444749
UMLS CUI [1,3]
C0015127
UMLS CUI [1,4]
C0042210
UMLS CUI [1,5]
C1705248
UMLS CUI [2,1]
C1527304
UMLS CUI [2,2]
C1444749
UMLS CUI [2,3]
C0015127
UMLS CUI [2,4]
C0042210
UMLS CUI [2,5]
C1705248
acute disease at the time of enrolment. (acute disease is defined as the presence of a moderate or severe illness with or without fever. all vaccines can be administered to persons with a minor illness such as diarrhoea, mild upper respiratory infection with or without low-grade febrile illness, i.e. oral temperature < 37.5°c (99.5°f) /
Descrição

Disease | Disease Moderate | Disease Severe | Fever | Vaccines | minor (disease) | Diarrhea | Upper Respiratory Infection Mild | Disorder characterized by fever Low grade | Oral temperature Degrees Celsius | Oral temperature Degrees fahrenheit

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0012634
UMLS CUI [2,1]
C0012634
UMLS CUI [2,2]
C0205081
UMLS CUI [3,1]
C0012634
UMLS CUI [3,2]
C0205082
UMLS CUI [4]
C0015967
UMLS CUI [5]
C0042210
UMLS CUI [6]
C1446899
UMLS CUI [7]
C0011991
UMLS CUI [8,1]
C0041912
UMLS CUI [8,2]
C2945599
UMLS CUI [9,1]
C0743841
UMLS CUI [9,2]
C1282907
UMLS CUI [10,1]
C1532216
UMLS CUI [10,2]
C0439237
UMLS CUI [11,1]
C1532216
UMLS CUI [11,2]
C0456628
axillary temperature <37.5°c (99.5°f).
Descrição

Axillary temperature

Tipo de dados

boolean

Alias
UMLS CUI [1]
C1531924
acute or chronic, clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by physical examination or laboratory screening tests.
Descrição

Lung function abnormal | Abnormal cardiovascular function | Liver Dysfunction | Abnormal renal function | Lung function abnormal chronic | Abnormal cardiovascular function chronic | Liver Dysfunction chronic | Abnormal renal function chronic | Physical Examination | Laboratory Procedures

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0476405
UMLS CUI [2]
C0232090
UMLS CUI [3]
C0086565
UMLS CUI [4]
C0151746
UMLS CUI [5,1]
C0476405
UMLS CUI [5,2]
C0205191
UMLS CUI [6,1]
C0232090
UMLS CUI [6,2]
C0205191
UMLS CUI [7,1]
C0086565
UMLS CUI [7,2]
C0205191
UMLS CUI [8,1]
C0151746
UMLS CUI [8,2]
C0205191
UMLS CUI [9]
C0031809
UMLS CUI [10]
C0022885
administration of immunoglobulins and/or any blood products within the three months preceding the first dose of study vaccine or planned administration during the study period. pregnant or lactating female.
Descrição

Immunoglobulins | Blood product | Pregnancy | Breast Feeding

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0021027
UMLS CUI [2]
C0456388
UMLS CUI [3]
C0032961
UMLS CUI [4]
C0006147
female planning to become pregnant or planning to discontinue contraceptive precautions during the study period.
Descrição

Pregnancy, Planned | Contraceptive methods Discontinue Planned

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0032992
UMLS CUI [2,1]
C0700589
UMLS CUI [2,2]
C1444662
UMLS CUI [2,3]
C1301732
Voltar ao início da página

Similar models

Eligibility Hepatitis B NCT00197158

1 Formulários
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
a male or female >= 18 years of age
boolean
C0001779 (UMLS CUI [1])
Informed Consent
Item
written informed consent obtained from the subject.
boolean
C0021430 (UMLS CUI [1])
Health Problem Free of | Medical History | examination; clinical
Item
free of obvious health problems as established by medical history and clinical examination before entering into the study.
boolean
C0018684 (UMLS CUI [1,1])
C0033213 (UMLS CUI [1,2])
C0332296 (UMLS CUI [1,3])
C0262926 (UMLS CUI [2])
C1456356 (UMLS CUI [3])
Gender Childbearing Potential Absent | Female Sterilization | Postmenopausal state | Childbearing Potential Sexual Abstinence | Childbearing Potential Contraceptive methods | Childbearing Potential Pregnancy test negative | Vaccination
Item
if the subject is female, she must be of non-childbearing potential, i.e. either surgically sterilized or one year post-menopausal; or, if of childbearing potential, she must be abstinent or have used adequate contraceptive precautions for 30 days prior to vaccination, have a negative pregnancy test and must agree to continue such precautions for two months after completion of the vaccination series.
boolean
C0079399 (UMLS CUI [1,1])
C3831118 (UMLS CUI [1,2])
C0332197 (UMLS CUI [1,3])
C0015787 (UMLS CUI [2])
C0232970 (UMLS CUI [3])
C3831118 (UMLS CUI [4,1])
C0036899 (UMLS CUI [4,2])
C3831118 (UMLS CUI [5,1])
C0700589 (UMLS CUI [5,2])
C3831118 (UMLS CUI [6,1])
C0427780 (UMLS CUI [6,2])
C0042196 (UMLS CUI [7])
Item Group
C0680251 (UMLS CUI)
Investigational New Drugs | Drugs, Non-Prescription | Vaccine OTC - Over The Counter | Vaccine Clinical Trial
Item
use of any investigational or non-registered drug or vaccine other than the study vaccine during the study period.
boolean
C0013230 (UMLS CUI [1])
C0013231 (UMLS CUI [2])
C0042210 (UMLS CUI [3,1])
C2709201 (UMLS CUI [3,2])
C0042210 (UMLS CUI [4,1])
C0008976 (UMLS CUI [4,2])
Immunosuppressive Agents chronic | Biological Response Modifiers chronic | Adrenal Cortex Hormones | Prednisone U/day | Prednisone equivalent U/day | inhaled steroids | topical steroids
Item
chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within six months prior to the first vaccine dose. (for corticosteroids, this will mean prednisone, or equivalent, greater than or equal to 0.5 mg/kg/day. inhaled and topical steroids are allowed.)
boolean
C0021081 (UMLS CUI [1,1])
C0205191 (UMLS CUI [1,2])
C0005525 (UMLS CUI [2,1])
C0205191 (UMLS CUI [2,2])
C0001617 (UMLS CUI [3])
C0032952 (UMLS CUI [4,1])
C0456683 (UMLS CUI [4,2])
C0032952 (UMLS CUI [5,1])
C3242703 (UMLS CUI [5,2])
C0456683 (UMLS CUI [5,3])
C2065041 (UMLS CUI [6])
C2064827 (UMLS CUI [7])
Vaccine | Vaccine Planned
Item
planned administration/ administration of a vaccine not foreseen by the study protocol within 30 days of the first dose of vaccine.
boolean
C0042210 (UMLS CUI [1])
C0042210 (UMLS CUI [2,1])
C1301732 (UMLS CUI [2,2])
Hepatitis B vaccination
Item
previous vaccination against hepatitis b
boolean
C0474232 (UMLS CUI [1])
Hepatitis B
Item
history of hepatitis b infection
boolean
C0019163 (UMLS CUI [1])
Hepatitis B Exposure to
Item
known exposure to hepatitis b within the previous 6 weeks
boolean
C0019163 (UMLS CUI [1,1])
C0332157 (UMLS CUI [1,2])
Immunosuppression | Immunologic Deficiency | Immunosuppression Suspected | Immunologic Deficiency Suspected | HIV Infections
Item
any confirmed or suspected immunosuppressive or immunodeficient condition, including human immunodeficiency virus (hiv) infection.
boolean
C4048329 (UMLS CUI [1])
C0021051 (UMLS CUI [2])
C4048329 (UMLS CUI [3,1])
C0750491 (UMLS CUI [3,2])
C0021051 (UMLS CUI [4,1])
C0750491 (UMLS CUI [4,2])
C0019693 (UMLS CUI [5])
Immunodeficiency congenital Family history | Immunologic Deficiency Hereditary Family history
Item
a family history of congenital or hereditary immunodeficiency.
boolean
C0853602 (UMLS CUI [1,1])
C0241889 (UMLS CUI [1,2])
C0021051 (UMLS CUI [2,1])
C0439660 (UMLS CUI [2,2])
C0241889 (UMLS CUI [2,3])
Hypersensitivity Exacerbated Caused by Vaccine Component | Allergic Reaction Exacerbated Caused by Vaccine Component
Item
history of allergic disease or reactions likely to be exacerbated by any component of the vaccine(s).
boolean
C0020517 (UMLS CUI [1,1])
C1444749 (UMLS CUI [1,2])
C0015127 (UMLS CUI [1,3])
C0042210 (UMLS CUI [1,4])
C1705248 (UMLS CUI [1,5])
C1527304 (UMLS CUI [2,1])
C1444749 (UMLS CUI [2,2])
C0015127 (UMLS CUI [2,3])
C0042210 (UMLS CUI [2,4])
C1705248 (UMLS CUI [2,5])
Disease | Disease Moderate | Disease Severe | Fever | Vaccines | minor (disease) | Diarrhea | Upper Respiratory Infection Mild | Disorder characterized by fever Low grade | Oral temperature Degrees Celsius | Oral temperature Degrees fahrenheit
Item
acute disease at the time of enrolment. (acute disease is defined as the presence of a moderate or severe illness with or without fever. all vaccines can be administered to persons with a minor illness such as diarrhoea, mild upper respiratory infection with or without low-grade febrile illness, i.e. oral temperature < 37.5°c (99.5°f) /
boolean
C0012634 (UMLS CUI [1])
C0012634 (UMLS CUI [2,1])
C0205081 (UMLS CUI [2,2])
C0012634 (UMLS CUI [3,1])
C0205082 (UMLS CUI [3,2])
C0015967 (UMLS CUI [4])
C0042210 (UMLS CUI [5])
C1446899 (UMLS CUI [6])
C0011991 (UMLS CUI [7])
C0041912 (UMLS CUI [8,1])
C2945599 (UMLS CUI [8,2])
C0743841 (UMLS CUI [9,1])
C1282907 (UMLS CUI [9,2])
C1532216 (UMLS CUI [10,1])
C0439237 (UMLS CUI [10,2])
C1532216 (UMLS CUI [11,1])
C0456628 (UMLS CUI [11,2])
Axillary temperature
Item
axillary temperature <37.5°c (99.5°f).
boolean
C1531924 (UMLS CUI [1])
Lung function abnormal | Abnormal cardiovascular function | Liver Dysfunction | Abnormal renal function | Lung function abnormal chronic | Abnormal cardiovascular function chronic | Liver Dysfunction chronic | Abnormal renal function chronic | Physical Examination | Laboratory Procedures
Item
acute or chronic, clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by physical examination or laboratory screening tests.
boolean
C0476405 (UMLS CUI [1])
C0232090 (UMLS CUI [2])
C0086565 (UMLS CUI [3])
C0151746 (UMLS CUI [4])
C0476405 (UMLS CUI [5,1])
C0205191 (UMLS CUI [5,2])
C0232090 (UMLS CUI [6,1])
C0205191 (UMLS CUI [6,2])
C0086565 (UMLS CUI [7,1])
C0205191 (UMLS CUI [7,2])
C0151746 (UMLS CUI [8,1])
C0205191 (UMLS CUI [8,2])
C0031809 (UMLS CUI [9])
C0022885 (UMLS CUI [10])
Immunoglobulins | Blood product | Pregnancy | Breast Feeding
Item
administration of immunoglobulins and/or any blood products within the three months preceding the first dose of study vaccine or planned administration during the study period. pregnant or lactating female.
boolean
C0021027 (UMLS CUI [1])
C0456388 (UMLS CUI [2])
C0032961 (UMLS CUI [3])
C0006147 (UMLS CUI [4])
Pregnancy, Planned | Contraceptive methods Discontinue Planned
Item
female planning to become pregnant or planning to discontinue contraceptive precautions during the study period.
boolean
C0032992 (UMLS CUI [1])
C0700589 (UMLS CUI [2,1])
C1444662 (UMLS CUI [2,2])
C1301732 (UMLS CUI [2,3])
Voltar ao início da página 

Contacto

Use este formulário para feedback, perguntas e sugestões de aperfeiçoamento.

Campos marcados com * são obrigatórios.

Ajuda

Do you need help on how to use the search function? Please watch the corresponding tutorial video for more details and learn how to use the search function most efficiently.

Watch Tutorial